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Pharmaceutical Manufacturing and Packing Sourcer
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| Jim Baxter at Maxiom Group addresses the impact outsourcing has had on the supply chain, and explores the solutions which attempt to limit the risks
Many pharmaceutical companies operate as a ‘virtual manufacturer’, outsourcing several steps in the supply chain such as API/drug substance, manufacturing, bulk product manufacturing and packaging. Even though these companies may outsource, they still have responsibility and ownership for the pharmaceutical at all stages of the supply chain, and need to keep track of and manage their outsourced vendors. Otherwise, they may risk regulatory penalties, loss of product and contractual liability.
The collection, organisation, analysis and dissemination of the information necessary to manage virtual supply chain relationships pose both business and technical challenges for the pharmaceutical licensee. Figure 1 is an example of the flow of both material and information through the supply chain for a pharmaceutical product.
It shows the supply chain for just one product and, as companies expand their product portfolio, they add more supply chain partners, increasing the complexity of managing the processes. Many of the same challenges exist for both clinical and commercial products, even though the volumes may increase when the product is approved and becomes commercially available.
PRIMARY BUSINESS DRIVERS
Contractual obligations, regulatory compliance and cost management are the primary business drivers in the search for a visibility solution. Bidirectional contracts will stipulate items such as delivery time frames, expected yields and quality inspections that need to be passed in order to meet agreed obligations. Failure to meet those obligations could incur financial penalties or, in extreme cases, might result in the cancellation of contracts. The European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) have strict requirements regarding lot tracking and traceability, primarily around the time frame for executing a product recall. Many companies in the supply chain issue their own lot numbers and, during a paper based recall, this adds to the time, complexity and workload of executing this recall. |
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As Vice President of the Solutions Practice at Maxiom Group, Jim Baxter directs a group of professionals and works directly with clients to deliver technology strategy and solutions. As a technology generalist, his previous experience includes leading consulting practices focused in enterprise portals and collaboration, enterprise resource planning, eBusiness and systems integration. Jim’s experience extends around the globe, including solution delivery in Europe and sales management for the Middle East, Africa and Asia/Pacific. He has also been a key player on a number of mergers, partnering and corporate integration initiatives. Prior to Maxiom Group, Jim held senior positions at Unitas Corporation, The Convergent Group and CSC Consulting Group. He holds a BS in Computer Science from the University of St Andrews, Scotland. |
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Small Scale Biomanufacturing – clinical trials, cell & gene therapies
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This one day conference, sponsored by bioProcessUK and organised by BioApproaches South West, will cover key, important topics relating to small scale GMP biomanufacturing.
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